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Posts Tagged ‘FDA’

FDA Reboots Tobacco Regulation with Harm Reduction

Tuesday, August 15th, 2017

On Friday, July 28, 2017, U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb unveiled a revamped approach to tobacco product regulation in an announcement that surprised tobacco companies, investors, and the public health community in equal measure.  The goal, as articulated by Gottlieb, will be to regulate products so as to encourage migrating existing consumers from the most lethal combustible tobacco products (i.e., cigarettes) to non-combustible products lower on the continuum of risk. This approach is known as “harm reduction.”  The keystone will be to promulgate product standards so that cigarettes deliver insufficient nicotine to users to create or sustain addiction so that current nonsmokers never start and current smokers either quit or switch to non-combustible tobacco product that present a lower health risk.

This idea, while somewhat radical, is not new.  It had been a topic of discussion at the American Medical Association in the mid-1990s. Congress gave the FDA regulatory authority over tobacco in 2009 with the Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Control Act”).  It prohibited the agency from banning cigarettes or from banning nicotine.  The law does, however, explicitly allow for the potential reduction of nicotine in cigarettes to any level above zero.  The Public Health Advocacy Institute at Northeastern University School of Law produced a white paper on this approach in 2009 and proposed further research on the policy, but enthusiasm at the agency and the Executive Branch was lacking. Northeastern University Distinguished Professor, Richard A. Daynard, characterized non-addictive cigarettes in the New York Times as one of two important strategies that could end the cycle of addiction, disease, and death from tobacco products.

Research to date, including a $50 million research project funded by the National Institute on Drug Abuse, have produced preliminary results supporting the notion that very low nicotine cigarettes will lead to fewer cigarettes smoked and reduced toxic exposure to consumers.  So long as the nicotine levels are very low, compensatory smoking behaviors such as inhaling more deeply and smoking greater numbers of cigarettes do not seem to generally occur.  Some of these preliminary results were presented at Northeastern University School of Law in 2014 by a Principal Investigator of the grant, Dorothy Hatsukami, at PHAI’s conference, “Accelerating Tobacco Endgame Strategies in the United States.”

Another important tool that the FDA can use is to issue rules pertaining to the use of flavors in tobacco products.  While the Tobacco Control Act banned the use of characterizing flavors other than mint or menthol in cigarettes, concerns around the role of flavors in tobacco initiation have intensified in recent years.  “Little cigars,” which closely resemble cigarettes, are available in a range of child-friendly flavors.  E-cigarettes, likewise, have been criticized for offering fruit and candy flavors that would seem to appeal to children.

The question of exempting menthol flavored cigarettes from the flavor ban has been extremely controversial.  The Tobacco Control Act, it was thought, would not have garnered the votes needed to pass Congress were a menthol cigarette ban included.  Rather, the law specified that an expert committee must be convened by FDA to study the issue and issue a report on the health impact of menthol as a characterizing flavor in tobacco products.

The resulting reports concluded that although menthol itself did not contribute to the toxicity of tobacco products, it tended to anesthetize the lungs in a way that facilitates smoking initiation by youth and frustrated cessation efforts.  Further, mentholated cigarettes have been historically marketed in a way that targets African Americans.  Almost 90% of African American smokers prefer menthol cigarettes, which is the most robust sector of the cigarette industry in the United States.  The company that produces the menthol market leader, Newport, was recently acquired by R.J. Reynolds which, in turn, was acquired by British American Tobacco this year. Reportedly, much of the value sought in these acquisitions derived from the Newport brand and the value of menthol cigarettes.

To date, the FDA has taken no action on mentholated tobacco products.  Chicago and San Francisco have passed ordinances restricting sales of menthol tobacco products.  San Francisco’s ordinance, which passed in July of 2017, is a total ban on all flavored tobacco product sales, including menthol.

The FDA announced that it will soon release three Preliminary Notice of Proposed Rulemakings seeking public and stakeholder comment on: 1) pros and cons of nicotine reduction strategies; 2) role of characterizing flavors, including menthol, in youth initiation and as a means to attract smokers to non-combustible tobacco products with less risk; and 3) potential health risks and use patterns of premium cigars.

Non-combustible products such as electronic nicotine delivery systems including e-cigarettes and emerging “heat-not-burn” products would be likely alternatives to non-addictive cigarettes as would nicotine replacement therapies such as the gum and patch.  While this harm reduction approach has many supporters in the public health community, it would have the likely effect of perpetuating the commercialized recreational use of nicotine long into the future.

Since the FDA began regulating tobacco products in 2009, almost every substantive regulatory effort has been met with litigation. This includes 2 lawsuits challenging a host of the law’s provisions; challenges to the legal legitimacy of the report FDA issued about menthol; a successful First Amendment challenge to regulations for graphic cigarette warning labels; and a dozen or so lawsuits challenging the agency’s regulation of e-cigarettes and cigars.

This litany of litigation has, to this point, slowed or partially derailed the agency’s regulatory agenda and has drawn the criticism of many in the public health community. The FDA’s announcement marks a new and more aggressive regulatory vision for tobacco. Many questions remain. Is the scientific evidence base sufficient to justify this new approach?  What will be the effect of inevitable legal challenges from manufacturers and smokers? What are the health impact of non-combustible tobacco products to users and non-users?  How did the political environment in the Executive Branch change to allow for this new strategy to emerge and will it last?

With so many questions remaining and so many potential rules to enact, the timeline for the FDA to implement its new regulatory approach is uncertain.  Based on past experience, it would be reasonable to expect that it may be a decade or more until cigarettes are non-addictive.  Until then, there will be an effort by the tobacco industry to attract millions of consumers to new, less dangerous, but still addictive tobacco products.

Author –  Public Health Advocacy Institute
Reprinted from:

PHAI’s Gottlieb Comments on FDA Regulations’ Effect on Vaping Industry on All Things Considered

Wednesday, August 24th, 2016

On August 8, 2016, new regulations by the FDA went into effect that have a profound impact on a major segment of the electronic cigarette industry:  vape shops.  The shops that mix flavors for vaping products are now considered to be manufacturers and subject to the same requirements as manufactures owned by the companies that make Marlboros, Camels, and Newports.

The new rules will require each and every flavor variation of electronic cigarettes to be approved by the FDA as a new tobacco product.  The cost associated with each application is estimated by the agency to average over $300,000.  Vape shops had typically created many dozens of varieties of “e-juice” every month and, under the new rules, the revenues from these flavor varieties would account for only a small fraction of the cost for submitting new tobacco product applications. This has led some vape shops to close their doors.

WGBH’s Isaiah Thompson reported on these developments  for NPR’s All Things Considered (with an expanded written version). PHAI’s executive director, Mark Gottlieb, is quoted in the piece.

Vape Shop

PHAI Submits Comments to FDA on Deeming Rule Focusing on E-Cigarettes

Friday, August 8th, 2014

Today the Public Health Advocacy Institute submitted comments  to the U.S. Food and Drug Administration on its proposed rule to include cigars, little cigars, electronic cigarette products, and tobacco for hookah smoking among the products for which it can legally issues rules and regulations.  This is known as a “deeming rule.”  The deeming rule is a first step toward regulating tobacco products beyond the cigarettes, smokeless tobacco, and roll-your-own products that the agency now regulates through its Center for Tobacco Products.

The Center for Tobacco Products solicited a wide range of comments and posed many questions to stakeholders and the public in its proposed rule.  PHAI focused its comments on the question of how best to regulate electronic cigarettes once they have been deemed tobacco products and are regulated by the FDA.

PHAI found that the vast majority of the American public believes that electronic cigarettes are a reduced risk product and that manufacturers and sellers of electronic cigarettes have marketed their products directly and indirectly as safer products.  Only tobacco products that are approved as “modified risk tobacco products” are permitted to advertise and market their products as posing a reduced risk to users.  As a result, electronic cigarette advertising focuses on other sorts of appeals such as sex appeal and conceptual themes that may attract new users and result in youth initiation. Electronic cigarettes are supposed to be an alternative to the most dangerous tobacco product, cigarettes, not a new pathway to addiction and eventual cigarette use for young people.

Electronic cigarette companies are benefiting from the perception that these are reduced risk products without going through the necessary approval process to attain that status from the FDA.

PHAI recommends:

1. Electronic cigarettes should not be approved as “new tobacco products” because the public already believes that they are reduced risk products.

2. Electronic cigarette manufacturers should apply for approval by FDA under the “modified risk tobacco product” category and demonstrate that their products will be a real benefit to public health.

3. FDA should require a statement in all electronic cigarette advertising stating that the agency has approved the product as a “modified risk tobacco product.”  If electronic cigarettes were approved only as “new tobacco products,” they could not advertise because they could not carry the statement required on all advertising.  This would ensure that there would only be advertising for electronic cigarettes that were demonstrated to be beneficial to public health and drive consumers to purchase those products that carry the proposed required FDA statement.

4. In addition, PHAI urged the agency to include premium cigars in its regulatory authority by deeming them to be tobacco products.  Even if there is no need to impose new rules on premium cigars at this time, if the need did arise, having already deemed these tobacco products as “tobacco products” for regulatory purposes would allow the FDA to issue rules and regulation should evidence indicate such a need.


5. PHAI urged the FDA to develop comprehensive regulations for flavors in all newly deemed tobacco products.  Candy flavors should be banned and any other flavors proposed to be retained by manufacturers should only be approved upon a showing that the flavor contributes to improving public health.

You can download PHAI’s comment here.

PHAI’s Gottlieb Calls Out FDA and White House for Failing to Aggressively Implement the Family Smoking Prevention and Tobacco Control Act

Monday, April 14th, 2014

In an editorial published in the May, 2014 issue of the journal, Tobacco Control, PHAI’s Executive Director, Mark Gottlieb, calls the FDA’s approach to implementation of the Family Smoking Prevention and Tobacco Control Act, “Overcautious,” and urges the agency and the White House to take a much more aggressive approach to saving lives.

The summary of the editorial, entitled “Overcautious FDA has Lost its Way,” states:

Five years after the passage of the Family Smoking Prevention and Tobacco Control Act, little progress has been made in the effort to regulate the US tobacco industry and advance the public health goals of tobacco control. Legal challenges by the tobacco industry, and evidence of political interference from the White House have resulted in the US Food and Drug Administration’s (FDA) overcautious approach toward advancing a meaningful regulatory agenda. While the White House bears final responsibility, it is incumbent upon the FDA and its Center for Tobacco Products to become more aggressive and seize the extraordinary opportunity to save lives that the Family Smoking Prevention and Tobacco Control Act has created.

Despite the capabilities of the FDA’s Center for Tobacco Products and its director, Mitchell Zeller, who directed the FDA’s tobacco efforts in the 1990s under commissioner David Kessler, progress in meaningfully regulating tobacco products is moving at a glacial pace. Predictably, the tobacco industry is utilizing its full legal arsenal to challenge and delay FDA’s efforts.   It is  becoming apparent that the White House is also responsible for the FDA’s inaction through delays caused by its Office of Management and Budget.

Gottlieb believes that the agency should be: (1) eliminating menthol; (2) regulating nicotine levels to reduce dramatically abuse liability and toxic exposure; (3) implementing arresting and effective graphic warnings; (4) facilitating an increase of the national minimum tobacco sales age to 21; and (5) responsibly controlling new tobacco products’ entry into the market. This is simply not happening.

Gottlieb suggests that because litigation by the tobacco industry to challenge regulatory action is inevitable, the best strategy is for the FDA to use the best available evidence now and rollout the regulatory agenda as fast as the law will allow.  Delay only serves to benefit the industry and, consequently, increase the morbidity and mortality that the industry’s products cause in the United States.

Another suggestion by Gottlieb is for FDA to consider how Sharon Eubanks, lead attorney for the U.S. Department of Justice, handled similar legal and political challenges when litigating the racketeering case, U.S. v. Philip Morris.

The editorial concludes by noting that, “[t]here exists no better public health opportunity of any kind than this one, now in the hands of the FDA. They should run with it, not from it.”


PHAI urges FDA to prohibit the sale and distribution of menthol cigarettes

Friday, November 22nd, 2013

On July 24, 2013, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) seeking comments from the public and other stakeholders on the potential regulation of menthol in cigarettes.   Gottlieb and Daynard from PHAI submitted comments today on Docket No. FDA-2013-N-0521 calling on the Secretary of Health and Human Services to promulgate regulations to pursuant to her authority under sec. 906 of the Family Smoking Prevention and Tobacco Control Act to  prohibit cigarette manufacturers from selling or distributing cigarettes that are:

a) Branded as a menthol product;
b) Marketed as a successor to a previously marketed menthol product; or
c) Otherwise likely to be perceived as a menthol product or menthol product successor in the marketplace.

The FDA’s staff issued a peer-reviewed comprehensive scientific report as did the agency’s Tobacco Products Scientific Advisory Committee in 2011.  We noted that, “these findings clearly establish an evidence base that justifies regulatory action by the Secretary to stop the harm to public health caused by permitting mentholated cigarettes to remain on the market.  To put it simply, the most acute harm appears to be that mentholated cigarettes facilitate smoking initiation by youth, frustrate quit attempts by addicted smokers, and include brands that have particularly targeted African Americans in a way that amplifies health disparities.”

Despite a years-long process, we are cautiously optimistic that FDA will move forward with regulations such as those we recommend in the near future.

View our comments here.


Lorillard Inc., v. United States Food and Drug Administration, No. 11-440

Monday, July 8th, 2013

On February 21, 2011, Lorillard Tobacco Company and R.J. Reynolds Tobacco Company filed a complaint[1] against the FDA in the United States District Court for the District of Columbia challenging the composition of the Tobacco Products Scientific Advisory Committee (“TPSAC”) and alleging that TPSAC failed to comply with the Federal Advisory Committee Act (“FACA”). TPSAC was formed immediately following the passage of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”). TPSAC was charged with researching the health effects of menthol in cigarettes and reported to the FDA that mentholated cigarettes adversely affected public health, and that their removal from the market would benefit public health.[2]

In their complaint, the tobacco companies allege that three members of TPSAC have financial and appearance conflicts of interest stemming from their continued service as paid expert witnesses in anti-tobacco litigation, as well as their continued employment for pharmaceutical companies that manufacture smoking-cessation products.[3] The tobacco companies argue that this creates an unbalanced committee representing only one set of viewpoints that are against smokeless tobacco products and menthol in cigarettes.[4]

Lorillard and R.J. Reynolds alleged injuries include disclosure of confidential information to conflicted committee members who could use it to testify for parties adverse to them, that the conflicted members have the ability to shape the TPSAC report to help with their work as expert witnesses, that Lorillard lost 2 billion in shareholder value, and that their procedural right to fair decision making was violated.[5] The companies are seeking declaratory relief that the three committee members violated FACA, as well as an injunction preventing the FDA from receiving or considering any suggestions from TPSAC pending the result of this litigation.[6]

On April 29, 2011, the FDA moved to dismiss the suit for lack of subject matter jurisdiction and failure to state a claim. The FDA argued that the tobacco companies lacked standing to challenge the committee’s composition because their alleged injuries were speculative, not traceable to the FDA, and were unlikely to be redressed by the court.[7] Furthermore, the FDA argued that any conflicts of interest are within FDA discretion and are not subject to judicial review.

On August 1, 2012, the U.S. District Court for the District of Columbia denied the FDA’s motion in its entirety.[8] The court held that Lorillard and R.J. Reynolds pled sufficient injuries and that the conflicts of interest are justiciable by the court.[9] Due to the limited number of viewpoints regarding tobacco issues and the scientific, rather than political, nature of the issues, the court determined they are equipped with sufficient standards against which it can assess the committee’s objectiveness.[10] With the denial of the FDA’s motion to dismiss, the tobacco companies are able to proceed with their suit.

On July 21, 2014, Judge Richard Leon granted Lorillard’s Motion for Summary Judgment to bar the Committee’s menthol report from consideration and orders the agency to reconstitute the Committee.  The judge found that the, “the Committee’s findings and recommendations, including reports such as the Menthol Report, are, at a minimum, suspect, and, at worst, untrustworthy.”[11]  The FDA has not yet announced whether it would appeal the ruling.

The FDA appealed Judge Leon’s ruling to the U.S. Court of Appeals for the DC Circuit which reversed the District Court’s ruling in a January 16, 2016 decision.  [12]   The Court considered the plaintiff/appellee’s  three alleged injuries and found none of them to be imminent enough to confer standing.  It, therefore, vacated the District Court’s judgment for lack of standing and dissolved Judge Leon’s injunction preventing the agency from utilizing the Menthol Report issued by the Tobacco Products Scientific Advisory Committee.

2012 Summary by Katelyn Blaney, updated by Mark Gottlieb in 2016.

[1]Online Copy of Initial Complaint:

[2] The Tobacco Products Scientific Advisory Committee, Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations, Chapter 8, p. 220 (March, 2011).

[3] 2d Amended Complaint at ¶ 2, Lorillard, Inc. v. U.S. Food & Drug Admin., No. 11-440 (RJL), 2012 WL 3542228 (D.D.C. 2012).

[4] Id. at ¶ 3.

[5] Lorillard, Inc v. United States Food & Drug Admin., No. 11-440 (RJL), 2012 WL 3542228, at *2 (D.D.C. 2012).

[6] Id. at ¶ 4.

[7] Lorillard, No. 11-440 (RJL), 2012 WL 3542228, at *2 (D.D.C. 2012).

[8] Id. at *1.

[9] Id. at *2.

[10] Id. at *2.

[11]  Lorillard Inc v. United States Food and Drug Administration, Civil Action No. 2011-0440 (D.C. 2014) District Court, District of Columbia.

[12] RJ Reynolds Tobacco v. US FOOD AND DRUG ADMIN. 810 F. 3d 827 – Court of Appeals, Dist. of Columbia Circuit 2016.

R.J. Reynolds Tobacco Co. v. Food & Drug Admin., NO. 11-5332

Monday, July 8th, 2013

In August, 2011, five tobacco companies[1] filed a complaint[2] against the FDA in the United States District Court for the District of Columbia alleging that certain provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) violated their First Amendment right to free speech.[3] The tobacco companies challenged the graphic warning requirements which mandated that new graphic warning labels must comprise the top 50% of the front and back panels of cigarette packages, and 20% of each cigarette advertisement. The labels include textual warnings, graphic warnings, and a “1-800-QUIT-NOW” hotline.

Any attempts by the government to infringe on free speech must meet “strict scrutiny,” meaning that the government must assert a compelling interest for subsidizing the speech and must use narrowly tailored means to do so. There are two exceptions to the strict scrutiny rule when the government is dealing with commercial speech.[4] The first, known as the Zauderer test, is that factual and uncontroversial disclosures of information are considered permissible under the First Amendment if they are reasonably related to the government’s interest in preventing consumer deception and are not overly burdensome.[5] The other, the Central Hudson test, allows restrictions on commercial speech if the government can prove their interest is substantial, the restriction materially advances that interest, and the restriction is narrowly tailored.[6]

The District Court granted a preliminary injunction on the graphic warning requirements and granted summary judgment for the tobacco industry. The District Court held that the graphic warnings were not factual and uncontroversial disclosures of information that would fit into the Zauderer test. Using strict scrutiny, the District Court held that the FDA failed to show that the warnings were narrowly tailored to achieve a compelling government interest.[7]

A three-judge panel for the U.S. Court of Appeals for the D.C. Circuit affirmed, 2-1, that the graphic warning requirements are an unconstitutional violation of the tobacco industry’s first amendment protections, but held so under different reasoning. Similar to the District Court, The Court of Appeals held that the graphic warnings could not be analyzed under the Zauderer standard.[8] The court stated that Zauderer only applies to avoid misleading or incomplete commercial advertisements. With the additional advertising regulations put in place by the Tobacco Act, such as a ban on labeling cigarettes as “light” or “mild”, the court held that there is no evidence that the graphic warnings are in place to combat deceptive claims.[9] Rather, the court viewed them as impermissible attempts by the FDA to discourage people from smoking.[10]

Alternatively, the Court of Appeals applied the Central Hudson standard, rather than the strict scrutiny test used by the District Court, to hold the graphic warning requirements unconstitutional.[11] While the Appellate Court acknowledged that the FDA’s interest in reducing smoking rates could qualify as a substantial interest, the Court ruled that the FDA failed to prove that the graphic warnings would reduce smoking rates.[12] The Court stated that the FDA did not provide “a shred of evidence” that these graphic warnings would actually lead to a reduction in smoking rates. [13] Thus, the graphic warning requirements failed to materially advance the government’s interest and are an unconstitutional limit on commercial speech.

The dissenting appellate judge would have upheld the graphic warning requirements, except for the “1-800-QUIT-NOW” hotline, under both the Zauderer and Central Hudson standards.[14] The judge wrote that Zauderer is the correct standard of review as the warning labels convey factually accurate information and prevent misleading commercial speech, noting the tobacco industry’s history of deceptive claims regarding the adverse health effects of smoking.[15]

The FDA’s petition for a rehearing of the case before all of the judges on the D.C. Court of Appeals was denied on December 5, 2012. On March 15, 2013, the Attorney General announced that the FDA would not petition for the Supreme Court to review the decision.

Summary by Katelyn Blaney

[1] R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.

[2] Online Copy of Initial Complaint:

[3] RJ Reynolds Tobacco Co. v. Food and Drug Administration, 696 F.3d 1205, 1208 (D.C. Cir, 2012).

[4] RJ Reynolds, 696 F.3d at 1212.

[5] Id.

[6] Id.

[7] Id. at 1212-13.

[8] Id. at 1214-15.

[9] Id. at 1215.

[10] Id. at 1216.

[11] Id. at 1217.

[12] Id. at 1218-19.

[13] Id. at 1219.

[14] Id. at 1223.

[15] Id. at 1222.

Disc. Tobacco City & Lottery, Inc. v. United States

Monday, July 8th, 2013

In August, 2009,  tobacco manufacturers and sellers[1]  brought suit[2] in the United States District Court for the Western District of Kentucky against the FDA, challenging provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”). In a case previously known as Commonwealth Brands, Inc v. United States, plaintiffs challenged the following requirements as violations of their First Amendment free speech protections, and sought a preliminary injunction barring the FDA from enforcing them, as well as a judgment declaring the provisions unconstitutional:

Graphic Warning Requirement: Tobacco manufacturers must reserve a portion of tobacco packaging for health warnings and graphic images

In Commonwealth Brands,[3] the District Court granted partial summary judgment in favor of the tobacco industry, holding both the color restrictions on their advertisements and the ban on safer product claims due to FDA regulation to be unconstitutional violations of the First Amendment. The District Court granted summary judgment in favor of the United States for every other challenged provision holding them to be constitutional. Both parties appealed this judgment to the Sixth Circuit Court of Appeals.

On March 29, 2012 a three-judge panel for the Sixth Circuit Court of Appeals upheld every contested provision of the Tobacco Act as constitutional, except for the restriction on the colors used in tobacco advertisements and the ban on continuity programs.[4]

Graphic Warning Requirement: In a 2-1 decision, the Court of Appeals held the graphic warning requirement to be constitutional. Arriving at this decision, the court distinguished between the Zauderer and Central Hudson standards of review for infringements on commercial speech, asserting that the former is reserved for disclosure requirements and the latter for prohibitions on speech.[5] The court viewed the graphic warnings as disclosures of factual information about the health risks of tobacco and, as such, evaluated them against Zauderer.[6] The Zauderer standard permits disclosure requirements as an infringement on commercial speech if they are reasonably related to the government’s interest in preventing consumer deception.[7] The court held that the graphic warning requirement was reasonably related to the FDA’s interest in preventing consumers from being mislead about the health risks of tobacco. The court noted the tobacco industry’s history of deceiving consumers about the health risks and addictiveness of tobacco, as well as the ineffectiveness of the current warnings on cigarette packaging, to hold that the graphic warnings are reasonably related to preventing consumer deception.[8]

The Court viewed the remaining provisions of the Act as prohibitions on speech and measured them against the Central Hudson standard. In order for restrictions on commercial speech to pass Central Hudson and be deemed permissible under the First Amendment, the government must assert a substantial interest in limiting the speech and the means by which they limit it must be narrowly tailored, meaning the government must use the least restrictive methods to further their interest.[9]

Restrictions on marketing “modified risk” tobacco products and the ban on implying tobacco product safety due to FDA regulation: Similar to the graphic warning requirement, the Court of Appeals found the government’s interest in preventing the tobacco industry from making fraudulent claims about the health effects of cigarettes to be substantial enough to satisfy the first prong of Central Hudson.[10] Under the Tobacco Act, in order for tobacco companies to market a product as “modified risk,” the FDA must first determine that the product will actually reduce the harm and risk of tobacco-related disease, taking into account first and second-hand smoke.[11] The court found the pre-approval of “modified risk” health claims to be sufficiently narrowly tailored to further the government’s interest in preventing consumer deception.[12] The Court of Appeals also held that the prohibition of claims that a tobacco product is safer, or less harmful, due to FDA regulation is narrowly tailored to prevent consumer deception. The Appellate Court, reversing the District Court on this count, saw this as a narrow infringement on the tobacco industry’s commercial speech that would otherwise mislead consumers into thinking the FDA endorses cigarettes and tobacco related products.[13]

 Ban on free samples of tobacco products and the ban on brand-name sponsorship and merchandising for non-tobacco related products: For these provisions of the Tobacco Act, the Court of Appeals found the government’s interest in curbing juvenile tobacco use to be substantial enough to limit the commercial speech of the tobacco industry.[14] The FDA produced considerable evidence showing that these specific marketing techniques reached an overwhelming number of juveniles. Based on this evidence, the Court found the ban on free samples of tobacco products, as well as the ban on any brand-name tobacco sponsorship of anything non-tobacco related, to be narrowly tailored to prevent juvenile tobacco use.[15]

Color restrictions in tobacco advertisements and the ban on continuity programs: Although the court decided that the government’s interest in protecting consumer deception was substantial, the court held that color restrictions of tobacco advertisements were too overbroad to further that interest.[16] The court stated that the government could have chosen less restrictive means to limit deceptive advertising, such as prohibiting specific images or phrases, rather than limiting them to black text on a white background.[17]

Furthermore, the court held that the tobacco industry’s continuity programs, in which companies offer benefits to existing customers, did not narrowly fit the government’s substantial interest of limiting juvenile tobacco use. The Appellate Court, reversing the District Court, relied on evidence which showed that most existing tobacco users are adults, thus, limiting the continuity programs would not have a material effect on curbing juvenile tobacco use.[18]

After the ruling in this case the tobacco industry petitioned for a Writ of Certiorari asking the Supreme Court to review the ruling (American Snuff Co v. United States). The Plaintiff’s Writ of Certiorari was denied on April 22, 2013.

Summary by Katelyn Blaney

[1] Discount Tobacco City & Lottery, Inc., Lorillard Tobacco Company, National Tobacco Company, L.P., R.J. Reynolds Tobacco Company, Commonwealth Brands, Inc., & American Snuff Company, LLC.

[2] Copy of Initial Complaint:

[3] District Court Decision:—dist-ct-sj-decision.pdf.

[4] Disc. Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 518 (6th Cir. 2012).

[5] Id. at 552.

[6] Id. at 558.

[7] Id. at 555.

[8] Id. at 562-63.

[9] Id. at 534.

[10] Id. 534-36.

[11] Id. at 531.

[12] Id. at 536-37.

[13] Id. at 551.

[14] Id. at 541.

[15] Id. at 541-43.

[16] Id. at 548.

[17] Id.

[18] Id. at 544.

Sottera, Inc. v. Food & Drug Admin.

Monday, July 8th, 2013

In April of 2009, Sottera, Inc., an importer and distributor of electronic cigarettes (“e-cigarettes”), sought a preliminary injunction barring the FDA from denying their products entry into the United States. E-cigarettes are “battery powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide.”[1] The nicotine in each e-cigarette is derived from tobacco plants. The FDA denied Sottera’s e-cigarette shipments entry into the U.S., asserting that e-cigarettes were unapproved drug-device combinations subject to their authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”).[2] The FDCA gives the FDA authority to regulate drugs, devices, or drug/device combinations.

In 2000, the Supreme Court decided in FDA v. Brown & Williamson, that the FDA did not have the FDCA authority to regulate tobacco products as customarily marketed, meaning tobacco products marketed without claims of therapeutic effect.[3] In 2009, the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) finally gave the FDA the authority to regulate customarily marketed tobacco products. The Tobacco Act defines tobacco products to include “all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combinations under the FDCA.”[4]

Sottera relied on Brown & Williamson to argue that e-cigarettes should be considered customarily marketed tobacco products such that the FDA has no authority under the FDCA to deny their products entry into the United States.[5] The FDA asserts that Brown & Williamson barred the FDA from regulating only those tobacco products that existed at the time the case was decided, and that e-cigarettes are properly regulated by the FDCA as a drug/device combination.[6]

The United States District Court for the District of Columbia granted a preliminary injunction barring the FDA from regulating e-cigarettes as drug/device products.[7] The Court held that Brown & Williamson precluded the FDA from treating e-cigarettes as a drug/device combination because e-cigarettes were customarily marketed tobacco products.

The D.C. Court of Appeals affirmed the District Court’s injunction barring the FDA from regulating e-cigarettes under the FDCA. The court held that e-cigarettes should be regulated as tobacco products under the Tobacco Act. The Court of Appeals stated that the holding in Brown & Williamson extended to all customarily marketed tobacco products.[8] Additionally, the court noted that the Tobacco Act specifically states that it does not “affect, expand, or limit” the FDA’s jurisdiction under the FDCA.[9] The Court of Appeals stated that,

 Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.[10]

 Thus, the Court of Appeals sided with Sottera, holding that e-cigarettes are customarily marketed tobacco products subject to FDA authority under the Tobacco Act, not the FDCA.

The FDA indicated it will not appeal the decision and will move forward with e-cigarette regulation through the Center for Tobacco Products.

Summary by Katelyn Blaney

[1] Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010).

[2] Id.

[3] Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 126 (2000).

[4] Sottera, 627 F.3d at 894.

[5] Id. at 893.

[6] Id. at 895.

[7] Online Link to District Court Decision:

[8] Id. at 895.

[9] Id. at 894.

[10] Id. at 898.

PHAI’s Gottlieb co-authors article on strategies to reduce cancer from indoor tanning, FDA seeks stronger regulation of lamps

Tuesday, May 7th, 2013

Tanning Bed

An article released today in the American Journal of Preventative Medicine by Holman et al. focuses on strategies to reduce indoor tanning.  Indoor tanning with sun lamps (as opposed to spray tanning)  increases the risk of malignant melanoma, the deadliest form of skin cancer.  This is particularly alarming because about one-third of white women(who are a high risk for skin cancer than others) in the U.S. have used sun lamps to tan within the past year averaging about 27 sessions over that time.  Many indoor tanning salon users are at even greater risk for skin cancer because  74% of tanning salons fail to adhere to FDA guidelines for tanning frequency.   The International Agency for Research on Cancer recently elevated tanning beds to its highest risk category as carcinogenic to humans.   Only 2 states prohibit tanning by minors (CA and VT).

There are some similarities between the way the indoor tanning and tobacco industries operate.   In fact, it appears that the tanning industry may be following the tobacco industry’s lead, particularly in its use of front groups and creating doubt around the science around the harm their products cause.

In 2010, the Federal Trade Commission settled a complaint against the Indoor Tanning Association for making deceptive claims about the risks and the benefits of indoor tanning.

In addition to legislative approaches to the problem and addressing research needs, one important intervention would be for the Food and Drug Administration to change the medical device classification for sunlamp products from class I to class II.  Class I is the medical device class used for tongue depressors. Today, the FDA pre-published proposed rules to reclassify sunlamps as class II devices (they will be published on May 9, 2013 and available here). Class II medical devices include products such as infusion pumps and surgical drapes.

Under the rules proposed today, manufacturers would have to: a) demonstrate to the FDA that indoor tanning lamps are safe for individuals; b) adjust UV wavelength to “appropriate” levels; c) install alarms and timers to prevent sunburn; and d) require users to read labels warning them of the dangers of UV exposure, including discouraging individuals under the age of 18 or those with a family history of cancer. Not only will these new requirements improve safety and reduce exposure to UV radiation indoors, they will also provide a strong reason for states to consider passing new or strengthening existing laws regulating tanning salons.

See: “Strategies to Reduce Indoor Tanning: Current Research Gaps and Future Opportunities for Prevention,” by Dawn M. Holman, MPH; Kathleen A Fox, MPP; Jeffrey D. Glenn, MPA; Gery P. Guy, Jr., PhD; Meg Watson, MPH; Katie Baker, MPH, DrPH(c); Vilma Cokkinides, PhD; Mark Gottlieb, JD; DeAnn Lazovich, PhD; Frank M Perna, EdD, PhD; Blake P Sampson, BS; Andrew B. Seidenberg, MPH; Craig Sinclair; Alan C. Geller, MPH, RN (DOI: 10.1016/j.amepre.2013.02.014)

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